The Effect of Mindfulness on Psychophysiological Stress in a Population With Elevated Stress Symptoms
Primary Purpose
Psychological Stress, Physiological Stress
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Headspace Basics Program
Headspace Breathing Exercises
Headspace Stress Program
Active Control (Audiobook)
Sponsored by
About this trial
This is an interventional basic science trial for Psychological Stress focused on measuring Stress, Mindfulness, HRV
Eligibility Criteria
Inclusion Criteria: Fluent in English Moderate to high perceived stress based on PSS total scores (14-40) Exclusion Criteria: Regular mindfulness practice for more than 1 month within the last year Medical diagnosis e.g. psychiatric/neurological conditions Low levels of stress (i.e., less than a score of 14 assessed with the PSS
Sites / Locations
- University of Southern Denmark. Department of Psychology.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
No Intervention
Arm Label
Headspace Basics Program
Headspace Breathing Exercises
Headspace Stress Program
Active Control (Audiobook)
Passive Control
Arm Description
Outcomes
Primary Outcome Measures
Perceived Stress Scale (PSS-10)
Heart rate variability (HRV)
HRV data will be recorded continuously during a rest period, acute stress period*, and recovery period at both pre and post on a subject-by-subject basis.
*The study will use an acute stress manipulation, specifically the CPT (Cold Pressor Task). The CPT is a standardized physiological acute stressor which has been shown to induce stress, reflected in autonomic stress reactivity (e.g. Lupien et al., 2007; Raio et al., 2017).
Secondary Outcome Measures
The Pittsburgh Sleep Quality Index (PSQI)
Mindful Attention Awareness Scale (MAAS)
Full Information
NCT ID
NCT05832632
First Posted
March 30, 2023
Last Updated
April 14, 2023
Sponsor
University of Southern Denmark
Collaborators
Headspace Health
1. Study Identification
Unique Protocol Identification Number
NCT05832632
Brief Title
The Effect of Mindfulness on Psychophysiological Stress in a Population With Elevated Stress Symptoms
Official Title
A Randomized Controlled Trial Comparing 3 Formats of Mindfulness Interventions to an Active Control Intervention in a Population With Elevated Levels of Stress: Effects of Subjective and Physiological Stress
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
October 4, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
Headspace Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stress-related disorders have over the last decade increased and contributed to a worldwide disease burden. At the same time there is limited treatment access for mental health disorders, which has left many people without necessary care. However, in recent years there has been a rise in digital mindfulness interventions. Specifically, these interventions have focused on smartphone-based applications as an effective format for mindfulness training programs. Thus, the goal of this randomized controlled trial is to test the effects of three types of mindfulness programs in a population with elevated stress. The three formats of mindfulness interventions are identical in total training duration but varies in content and intervention length. Specifically, the first intervention consists of programmatic mindfulness content that progress over the course of 30 sessions with a duration of 10 min per session. The second intervention consists of single succinct breathing exercises with no programmatic content over the course of 30 sessions with a duration of 10 min per session. The third intervention consists of mindfulness-based content specifically targeted to people with elevated stress that progress over the course of 20 sessions with a duration of 15 min per session. An active control group listening to an audiobook over the course of 30 sessions with a duration of 10 min per session will be employed and a passive control group.
The study will evaluate outcomes related to subjective stress, sleep quality, mindfulness and physiological effects of stress using HRV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Physiological Stress
Keywords
Stress, Mindfulness, HRV
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Headspace Basics Program
Arm Type
Experimental
Arm Title
Headspace Breathing Exercises
Arm Type
Experimental
Arm Title
Headspace Stress Program
Arm Type
Experimental
Arm Title
Active Control (Audiobook)
Arm Type
Active Comparator
Arm Title
Passive Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Headspace Basics Program
Intervention Description
30-day smartphone-based mindfulness intervention consisting of 10 minutes per day. The program consist of generic mindfulness techniques such as breath awareness, body scans, mindful noting of thoughts and emotions.
Intervention Type
Behavioral
Intervention Name(s)
Headspace Breathing Exercises
Intervention Description
30-day smartphone-based breathing exercises. Each exercise consists of box breathing for 1 minute and participants are instructed to complete 10 sessions corresponding to 10 minutes per day.
Intervention Type
Behavioral
Intervention Name(s)
Headspace Stress Program
Intervention Description
20-day smartphone-based mindfulness intervention consisting of 15 minutes per day. The Stress program content is based on well-established concepts and practices within stress management, and mindfulness, and is targeted to people with elevated stress.
Intervention Type
Behavioral
Intervention Name(s)
Active Control (Audiobook)
Intervention Description
30-day smartphone-based Audiobook book consisting of 10 minutes per day.
Primary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10)
Time Frame
immediately post intervention
Title
Heart rate variability (HRV)
Description
HRV data will be recorded continuously during a rest period, acute stress period*, and recovery period at both pre and post on a subject-by-subject basis.
*The study will use an acute stress manipulation, specifically the CPT (Cold Pressor Task). The CPT is a standardized physiological acute stressor which has been shown to induce stress, reflected in autonomic stress reactivity (e.g. Lupien et al., 2007; Raio et al., 2017).
Time Frame
immediately post intervention
Secondary Outcome Measure Information:
Title
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame
immediately post intervention
Title
Mindful Attention Awareness Scale (MAAS)
Time Frame
immediately post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fluent in English
Moderate to high perceived stress based on PSS total scores (14-40)
Exclusion Criteria:
Regular mindfulness practice for more than 1 month within the last year
Medical diagnosis e.g. psychiatric/neurological conditions
Low levels of stress (i.e., less than a score of 14 assessed with the PSS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Kirk, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Denmark. Department of Psychology.
City
Odense
ZIP/Postal Code
5230
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Cohen, S., & Janicki-Deverts, D. (2012), Who's Stressed? Distributions of Psychological Stress in the United States in Probability Samples from 1983, 2006, and 2009. Journal of Applied Social Psychology, 42: 1320-1334. https://doi.org/10.1111/j.1559-1816.2012.00900.x
Results Reference
background
PubMed Identifier
35663363
Citation
Tian F, Shen Q, Hu Y, Ye W, Valdimarsdottir UA, Song H, Fang F. Association of stress-related disorders with subsequent risk of all-cause and cause-specific mortality: A population-based and sibling-controlled cohort study. Lancet Reg Health Eur. 2022 May 28;18:100402. doi: 10.1016/j.lanepe.2022.100402. eCollection 2022 Jul.
Results Reference
background
Citation
World Health Organization. The impact of COVID-19 on mental, neurological and substance use services: results of rapid assessment. Geneva: World Health Organization; 2020. Available from: https://www.who.int/publications-detail-redirect/978924012455
Results Reference
background
PubMed Identifier
33822737
Citation
Sorkin DH, Janio EA, Eikey EV, Schneider M, Davis K, Schueller SM, Stadnick NA, Zheng K, Neary M, Safani D, Mukamel DB. Rise in Use of Digital Mental Health Tools and Technologies in the United States During the COVID-19 Pandemic: Survey Study. J Med Internet Res. 2021 Apr 16;23(4):e26994. doi: 10.2196/26994.
Results Reference
background
PubMed Identifier
35551058
Citation
Philippe TJ, Sikder N, Jackson A, Koblanski ME, Liow E, Pilarinos A, Vasarhelyi K. Digital Health Interventions for Delivery of Mental Health Care: Systematic and Comprehensive Meta-Review. JMIR Ment Health. 2022 May 12;9(5):e35159. doi: 10.2196/35159.
Results Reference
background
PubMed Identifier
28973957
Citation
Raio CM, Hartley CA, Orederu TA, Li J, Phelps EA. Stress attenuates the flexible updating of aversive value. Proc Natl Acad Sci U S A. 2017 Oct 17;114(42):11241-11246. doi: 10.1073/pnas.1702565114. Epub 2017 Oct 2.
Results Reference
background
PubMed Identifier
17466428
Citation
Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. doi: 10.1016/j.bandc.2007.02.007. Epub 2007 Apr 26.
Results Reference
background
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The Effect of Mindfulness on Psychophysiological Stress in a Population With Elevated Stress Symptoms
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